In April this year, the home radio frequency beauty device will be officially included in the management of Class III medical devices. Recently, the phenomenon of home beauty instruments, especially radio frequency beauty instruments, has continued to cause discussions, and a well-known brand product priced at nearly 3,000 yuan a few months ago has now fallen below 600 yuan. From "small household appliances" to "machine brands", some businesses have chosen to convert the track in the face of the high cost of household RF beauty instruments "holding a certificate".
The beauty effect of doing it at home lasts for a day or two.
Common home beauty devices can be roughly divided into cleaning, ultrasonic vibration, radiofrequency, etc., and on social platforms, radiofrequency beauty devices that claim to have "anti-aging" effects are hotly discussed. Ms. Jiang, a consumer, gritted her teeth and spent thousands of yuan to buy a home beauty device with radio frequency function. "I was attracted to being able to do beauty at home. But after using it, she found that the effect only lasted for a day or two at most. Slowly, there is no need for it," and then it was listed on the second-hand trading platform, and the price was only one-tenth of the original, but it has not been sold until now. ”
The reporter consulted a merchant who deals in beauty instrument products as a buyer. "From April, the RF beauty device products will enter a window period in the next one or two years. The merchant's reply is that the factory has shifted its production focus, and the RF beauty device is no longer stocked, but has switched to the production of LED beauty products such as red light beauty devices that are not subject to the new regulations.
The new regulations mentioned by the merchants refer to the regulatory regulations that the State Food and Drug Administration will implement on radio frequency beauty products. Among them, it is clear that from April 1, 2024, radio frequency instruments and radio frequency instruments shall not be produced, imported and sold without obtaining a medical device registration certificate in accordance with the law.
The depth of action is much inferior to that of medical equipment.
Before the new regulations were put into use, radio frequency beauty devices have been classified as "small household appliances" track, rather than according to the management of medical devices. Due to product design, quality and other reasons, the "overturning" incident is frequent, and the use effect has been controversial.
Radiofrequency beauty products use specific wavelengths of electromagnetic waves to stimulate the dermis, so that the high-frequency oscillation of water in the cells generates heat, so that the collagen is contracted by heat within a safe range, and stimulates new collagen synthesis. "Collagen contraction will have a lifting effect, but in order to maintain it in the long term, it is necessary to fundamentally increase the collagen production of ** cells. Feng Yongqiang, deputy chief physician of the Laser Beauty Center of the Plastic Surgery Hospital of the Chinese Academy of Medical Sciences, said bluntly that the power and depth of action of household equipment are far inferior to that of medical equipment, and the effect of increasing the production of the "collagen production line" in the first place is naturally limited.
Clinical trials cost four or five million.
Class III medical devices are the highest level of medical devices and the most tightly regulated medical devices. After the radio frequency beauty instrument is included in the supervision, it will usher in a healthier development space. However, to get a medical device registration certificate, the threshold is not low. "Clinical trials are estimated to cost four to five million dollars. A manufacturer engaged in the production of home beauty devices said that they are actively applying for relevant licenses, but the high cost of time and money has also "dissuaded" some peers.
Feng Yongqiang introduced that the clinical experiment of applying for a medical device registration certificate should preset improvement goals, calculate the required number of cases according to statistical principles, and cooperate with at least 3 units to carry out experiments.
It is understood that the non-inferiority test of a laser beauty medical device that is being carried out recently proves that the effect of the device is not worse than that of similar products, and nearly 1,000 patients need to participate. The part of the patient who received ** should also be randomly assigned, and after obtaining the experimental data, a third-party expert was invited to conduct a blind evaluation of the efficacy. Only when a statistically significant efficacy is achieved and the incidence of adverse reactions is lower than the relevant standards can it pass the review. It usually takes 3 to 5 years to complete this process.
Every small step in scientific and technological progress is not easy, and the home use of medical beauty equipment is indeed the focus of industry research and development. Feng Yongqiang believes that household equipment should not be equated with "shoddy manufacturing", and consumers should also have reasonable expectations for the effect of home beauty devices and strictly follow the instructions for use. If there is a higher demand for medical cosmetology, it is recommended to go to a regular medical institution for diagnosis and treatment.